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FDA Accepts Application for Potential Treatment for Lupus Nephritis, Gazyva®
Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, is eager to share exciting news. The U.S. Food and Drug Administration accepted the supplemental Biologics License Application (sBLA) from Genentech for Gazyva® (obinutuzumab) as a potential treatment of lupus nephritis. The acceptance is based on results from the Phase 3 REGENCY study showing improved complete renal response (CRR) with Gazyva plus standard therapy compared with standard therapy alone. This development provides hope for another treatment option for those living with lupus nephritis.
Source: Genentech 3.4.25 Press Release
